Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
A randomized, controlled study of standard soy milk consumption compared to 2% fat cow's milk consumption in children with Non-alcoholic Fatty Liver Disease (NAFLD). The investigators hypothesize that the daily consumption of soy isoflavones found in the soy milk will be beneficial in reducing NAFLD and other obesity-related comorbidities. The investigators do not expect any adverse endocrine or metabolomic effects from the consumption of soy isoflavones.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 12
Healthy Volunteers: f
View:
• Children with overweight/obesity
• Non-alcoholic fatty liver disease (NAFLD) and an MRI PDFF \>10%
• Known NAFLD or elevated ALT for sex (\>22 for females and \>26 for males)
Locations
United States
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Ann Popelar
Ann.Popelar@cchmc.org
(513) 636-8867
Time Frame
Start Date: 2024-01-15
Estimated Completion Date: 2026-06
Participants
Target number of participants: 44
Treatments
Placebo_comparator: 2% Fat Cows Milk
Participants randomized to this arm will consume 2% fat cow's milk twice daily for 12 weeks.
Experimental: Standard Soy Milk
Participants randomized to this arm will consume standard soy milk twice daily for 12 weeks.
Related Therapeutic Areas
Sponsors
Leads: Marialena Mouzaki